VERI-101 / VerImmune, Fosun Pharma - LARVOL DELTA

Safety and efficacy of VERI-101, a Virus-inspired Drug Conjugate, that redirects immune memory for cancer treatment (SITC 2025) - "In addition, VERI-003 or combination treatment led to statistically significant reductions in tumor growth and in certain cases, complete regression of tumors compared to untreated controls.Conclusions Overall, current data indicates a good safety profile for VERI-101 with no maximum tolerated dose observed. Collectively, our previous and current results demonstrate the tumor antigen-agnostic therapeutic potential of VERI-101 as a potentially safe and effective novel class of immuno-therapeutic drugs known as Virus-inspired Drug Conjugates (ViDCs), which can be used either as a monotherapy or in combination with checkpoint inhibitors.Ethics Approval This study was conducted under Aragen's Animal Use Protocol AUP_24-0516-M (Non-GLP Study: Evaluating Efficacy of Antiviral Biotherapeutics against mouse Cytomegalovirus infection in mice) and AUP_24-0712-MR (Oncology Preclinical Service: Anti-Cancer Efficacy and Other Studies (Pharmacokinetics, Pharmaco-dynamics, and MTD)..."

Clinical • IO biomarker • Oncology • CD8

Virus-inspired Particles (ViPs) harnessing cytomegalovirus immune memory for local and systemic cancer immunotherapy (AACR 2024) - "VerImmune's lead product, VERI-101, leverages pre-existing CD8+ T-cell immune memory acquired from past human cytomegalovirus (HCMV) infections...Anti-tumor effects of anti-PD-1 and combination were also observed. Additional studies are on-going to assess dose dependence and analysis of PK/PD effects.Taken together, our initial in vivo results demonstrate the tumor antigen-agnostic therapeutic potential of AIR and our AIR-ViP technology as a novel class of immuno-therapeutic drugs that could be used either as a monotherapy or in combination with checkpoint inhibitors."

Late-breaking abstract • Oncology • CD8

Redirecting immune memory for cancer treatment using virus-inspired drug conjugates (SITC 2023) - "To further demonstrate the biological proof of concept for VERI-101, we showed that an MCMV AIR-ViP (VERI-003, used as a surrogate as HCMV does not infect mice) administered either as a monotherapy or in combination with anti-PD-1 to MC38 tumor bearing mice with pre-existing MCMV immunity led to statistically significant reductions in tumor growth and in certain cases, complete regression of tumors compared to untreated controls. Conclusions In conclusion, our results demonstrate the tumor antigen-agnostic therapeutic potential of AIR and VERI-101 as novel class of immuno-therapeutic drugs known as Virus-inspired Drug Conjugates (ViDCs) that could be used either as a monotherapy or in combination with checkpoint inhibitors."

Oncology • CD8

VerImmune Inc. announces over $3M Additional Funding (PRNewswire) - " VerImmune Inc...announced today the securing of an additional $3.125 million from follow-on Seed financing and a partnership milestone payment....'We continue to be grateful to our internal team, network of advisors, existing investors, and pharmaceutical partners such as Fosun Pharma USA who believe in our technology platform and therapeutic potential of VERI-101. We intend to capitalize on this momentum and efficiently execute the next stages to enable the filing of an IND for VERI-101'."

Financing • Oncology • Solid Tumor

VerImmune Announces Positive Pre-IND Meeting with FDA (PRNewswire) - "VerImmune Inc...announced the successful completion of a Type B pre-IND meeting with the US Food and Drug Administration (FDA) for its groundbreaking VERI-101 immuno-oncology lead product for the treatment of multiple solid tumors. The primary objective of the pre-IND meeting was to seek FDA concurrence on VerImmune's manufacturing, control strategies and development plans, the design of non-clinical IND-enabling studies, and guidance on the proposed first-in-human clinical trial in cancer patients for VERI-101. The FDA provided clear and constructive feedback in the form of written responses to the Pre-IND package and questions submitted by VerImmune. This feedback from the FDA on the overall development strategy empowers VerImmune to advance towards the IND preparation and submission of VERI-101."

FDA event • Oncology • Solid Tumor